Phase III trial compares tisagenlecleucel to standard transplant in relapsed aggressive B-cell NHL

Status: COMPLETED | Phase: PHASE3 Condition(s): Non-Hodgkin Lymphoma Intervention(s): Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy (DRUG), Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT) (DRUG) This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy. Detailed: Approximately 318 subjects were planned to be randomized; 322 subjects were analyzed (Full analysis set): 162 subjects in the tisagenlecleucel arm and 160 subjects in the SOC arm. The target population consisted of adult participants with aggressive B-cell non-Hodgkin lymphoma (NHL) who were relapsed/refractory within 365 days of their last dose of first line immunochemotherapy and eligible for autologous hematopoietic stem cell transplantation (HSCT). The duration of treatment in the tisagenlecleucel treatment strategy is from the start of bridging chemotherapy (if applicable) until the infusion of tisagenlecleucel (expected on average at approximately 6 weeks from randomization). The duration of the treatment in the SOC treatment strategy is from the start of salvage chemotherapy until Primary Outcome(s): Event-free Survival (EFS) Per Blinded Independent Review Committee (BIRC) Assessment Enrollment: 331 (ACTUAL) Lead Sponsor: Novartis Pharmaceuticals Start: 2019-05-07 | Primary Completion: 2021-05-06 Results posted: 2024-07-23